The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio Dx to include Applied Biosystems' QuantStudio 5 Real-Time PCR system.
The amendment also authorizes the use of the Hamilton STARlet robotic automation in conjunction with the Omega Bio-tek Mag-Bind viral RNA Express kit to speed the process of extracting viral RNA from specimens and drive greater testing throughput.
The company believes the amendment can greatly enhance the efficiency of laboratories across the country who adopt the diagnostic kit while expanding by more than tenfold the target installed base of authorized RT-PCR equipment.
To match the potential for higher demand, the company is increasing production of its diagnostic kit.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.
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